W.L. Gore & Assocs., Inc. v. Medtronic, Inc., Civil Action No. 2:10cv441

• Court: United States District Courts. 4th Circuit. United States District Court (Eastern District of Virginia)
• Writing for the Court: Mark S. Davis
• Decision Date: 18 June 2012
• Docket Number: Civil Action No. 2:10cv441
• Parties: W.L. GORE & ASSOCIATES, INC., Plaintiff, v. MEDTRONIC, INC., MEDTRONIC USA, INC., and MEDTRONIC VASCULAR, INC., Defendants.

W.L. GORE & ASSOCIATES, INC., Plaintiff,
v.
MEDTRONIC, INC., MEDTRONIC USA, INC., and MEDTRONIC VASCULAR, INC., Defendants.

Civil Action No. 2:10cv441

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF VIRGINIA Norfolk Division

Dated: June 18, 2012

OPINION AND ORDER

I. INTRODUCTION

The patent infringement action before the Court was brought by Plaintiffs W.L. Gore & Associates, Inc., and Gore Enterprise Holdings, Inc.,¹ (collectively "Gore"), against defendants Medtronic, Inc., Medtronic USA Inc., and Medtronic Vascular

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Inc., (collectively "Medtronic"). The patent-in-suit claims a method of making a tubular intraluminal stent graft.

A five-day bench trial was held in February 2012. This Opinion and Order addresses and resolves all remaining motions and merits determinations and constitutes the Court's Findings of Fact and Conclusions of Law pursuant to Federal Rule of Civil Procedure 52(a).

II. BACKGROUND

A. Procedural Background

On September 3, 2010, Gore filed this suit against Medtronic, alleging infringement of Gore's United States Patent No. 5,810,870 ("the '870 patent"), entitled "Intraluminal Stent Graft." United States Patent No. 5,810,870 (filed on June 7, 1995) (issued on September 22, 1998), Joint Exhibit ("JX") 1. The *870 patent claims a "tubular intraluminal graft in the form of a tubular diametrically adjustable stent having a tubular covering of porus expanded polytetrafluoroethylene which is less than 0.10mm thick." '870 patent at Abstract. Gore alleges that Medtronic's Talent Abdominal Stent Graft, the AUI components to the Talent Abdominal Stent Graft, and the Talent Thoracic Stent Graft infringe claims 12, 16, and 19 of the '870 patent, which are directed to methods of making a tubular intraluminal stent graft.

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Medtronic moved to dismiss the Complaint on November 19, 2010, and on April 20, 2011 the Court issued an opinion denying Medtronic's motion to dismiss and granting Gore leave to amend the Complaint. ECF No. 40. On October 25, 2011, this Court conducted a hearing pursuant to Markman v. Westview Instruments, Inc., 517 U.S. 370, 372 (1996), and issued an Opinion and Order on December 16, 2011, construing the eight disputed claim terms. See W.L. Gore & Assocs., v. Medtronic Inc., 778 F. Supp. 2d 667, 2011 U.S. Dist. LEXIS 143585 (E.D. Va. 2011). Subsequently, on February 3, 2012, this Court issued an Opinion and Order denying Gore's Motion to Dismiss Medtronic's inequitable conduct counterclaim pursuant to Rule 12(b)(6). See W.L. Gore & Assocs., v. Medtronic Inc., 2012 U.S. Dist. LEXIS 13611 (E.D. Va. 2012).

The bench trial in this case commenced on February 13, 2012. On February 17, 2012, after final arguments had concluded, the Court took all outstanding issues under advisement and ordered preparation of a transcript of trial proceedings so that it could carefully consider the merits of the case.

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B. Witnesses at Trial

During the five-day bench trial, all parties were provided the opportunity to present evidence.² On the claim of infringement against Medtronic, Gore first called Dr. James Lewis, Bench Trial Transcript at 98, ECF No. 175, Dr. David J. Myers, Tr. at 146, and Mr. Wayne House, Tr. at 226, all of whom are listed inventors on the '870 patent. Gore also called Dr. Joel Berry, Tr. at 288, who was offered as an expert in stent grafts and the methods of manufacturing stent grafts. The Plaintiff also submitted a number of witnesses through deposition testimony:

• Mr. Treavor Greenan - a former engineer with World Medical who helped design the Talent stent graft. Tr. at 283.
• Mr. Richard Thomas - a former Medtronic employee who testified about the design and development of the Talent product. Tr. at 284.
• Mr. Gene Park - a former Medtronic employee who testified as to the Talent product's design and development. Tr. at 285.
• Mr. Mark Spreeman - a Medtronic employee who testified about the FDA process for the Talent device. Tr. at 286.
• Mr. Pedro Vargas - a Medtronic employee who testified about the manufacturing of the Talent device as well as the import/export process for the device. Tr. at 286.

Gore also offered Dr. Ace Baty, Tr. at 432, a Gore employee who testified as to the competitive market of stent grafts and the relationship between W.L. Gore and Gore Enterprise Holdings. Last, Dr. Jeffery Stec, Tr. at 505, was offered by Gore as an

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expert on the issue of damages. As a rebuttal witness, Gore later called Dr. Frank Veith, Tr. at 1040, and offered him as an expert in vascular surgery, endovascular procedures and stent grafts.

In response to Gore's infringement case, Medtronic offered Dr. Gary Loomis, Tr. 630, as an expert in the area of medical devices and materials for such devices, intraluminal devices, stents, grafts, and methods of making stents and grafts. Dr. Loomis offered his opinion of non-infringement as well as his opinion on the issue of obviousness. Medtronic also offered two fact witnesses through Mr. Roberto Flores, a Medtronic Mexico employee who testified as to the import/export process for the Talent device, Tr. 906, and Dr. Kweli Thompson, Tr. 930, the Vice President of Marketing for Medtronic's endovascular therapies business who testified to the competitive market for the Talent device. Additionally, Medtronic called Dr. Christopher Zarins, Tr. 1077, as an expert in the clinical use of stent grafts and vascular grafts for the treatment of aortic aneurysms. Last, Dr. Vince Thomas was offered as Medtronic's damages expert, Tr. 1004.

Having had the opportunity to observe the demeanor and hear the testimony of witnesses testifying live at trial, the Court has made certain credibility determinations, as well as determinations relating to the appropriate weight to accord the

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testimony. Such determinations are set forth below where relevant.

III. FINDINGS OF FACT

The Court's findings of fact are not limited to those in this section, but also include any credibility determinations or other determinations that appear below. Many of the Findings of Fact are substantiated with citations to testimony or documentary evidence or a combination thereof; however, such citations are not meant to be exhaustive authority for the finding. Some of the findings are based on the record or inferences from the record which are not cited. All proposed findings of fact and conclusions of law inconsistent with those set forth herein are rejected.

A. The '870 patent and claims

As noted above, the '870 patent was issued on September 22, 1998 and names David J. Myers, James D. Lewis, Wayne D. House, and Karl E. Schwarz as inventors.³ Stipulation of Undisputed Facts, ECF No. 150 at 10, ¶ 8. The '870 patent issued from U.S. Patent Application No. 479,931 ("the '931 application") which was filed on June 7, 1995. Id. at ¶ 9. The '931 application was a divisional application from U.S. Patent Application No.

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109,214 ("the *214 application") which was filed on August 18, 1993 and resulted in U.S. patent No. 5,735,892 ("the *892 patent" or "the parent patent"). Id. at ¶ 10. Both the '870 patent and the '892 parent patent contain the same specification. Loomis Direct, Tr. 635, ECF No. 177.

The asserted claims in this action are claims 12, 16 and 19 of the '870 patent. ECF. No 150 at ¶ 1. Claims 16 and 19 depend from independent claim 15. Loomis Direct, Tr. 645:13-17, ECF No. 177. The asserted claims are methods of making a tubular intraluminal graft and are set out below:

12. A method of making a tubular intraluminal graft comprising:
a) selecting at least one tubular, diametrically adjustable stent having an exterior surface, a luminal surface and a wall, and having a multiplicity of openings through the wall of the stent;
b) affixing a tubular covering to the exterior surface of the tubular, diametrically adjustable stent, said covering being less than 0.10 mm thick and said tubular covering having an exterior surface, a luminal surface and a seam extending from the exterior surface through to the luminal surface of the tubular covering.
15. A method of making a tubular intraluminal graft comprising:
a) selecting at least one tubular, diametrically adjustable stent having an exterior surface, a luminal surface and a wall, and having a multiplicity of openings through the wall, said tubular, diametrically adjustable stent having a collapsed diameter and an enlarged diameter wherein said enlarged diameter is at least 1.5 times the collapsed diameter, wherein said tubular, diametrically adjustable stent has been diametrically adjusted to the enlarged diameter;
b) affixing a tubular covering to the tubular, diametrically adjustable stent; and

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c)collapsing the tubular, diametrically adjustable stent to about the collapsed diameter
wherein the tubular covering is affixed to the exterior surface of the tubular, diametrically adjustable stent.
16. A method according to claim 15 wherein said tubular covering is less than about 0.10 mm thick.
17. A method according to claim 16 wherein said tubular covering is of porous expanded PTFE.

'870 Patent, col. 10, JX 1.

After the Markman hearing, the Court concluded the following definitions applied to the eight disputed terms:

"stent" means "elongated members forming a substantially cylindrical and rigid structure;"

"wall" means "a substantially cylindrical plane defined by the structure of the stent;"

"multiplicity of openings": "multiplicity" means "two or more" and "opening" requires no construction and was given its plain and ordinary meaning;

"covering" needed no construction and was given its plain and ordinary meaning to one of skill in the art. However, the Court expressly refused to limit the covering material only to ePTFE;

"affixing" needed no construction and was given its plain and ordinary meaning. However, the Court refused to limit the term "affixing" to any particular method;

"seam extending from the exterior surface through to the luminal surface of the tubular covering" needed no construction and was given its...